FDA — authorised 23 April 1979
- Application: ANDA062206
- Marketing authorisation holder: FACTA FARMA
- Local brand name: CEFACLOR
- Indication: FOR SUSPENSION — ORAL
- Status: approved
🇺🇸 Ceclor in United States
FDA authorised Ceclor on 23 April 1979
Marketing authorisations
FDA — authorised 28 July 1979
- Application: ANDA062205
- Marketing authorisation holder: CEPH INTL
- Local brand name: CEFACLOR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 May 1996
- Application: ANDA064148
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CEFACLOR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 June 1996
- Application: ANDA064145
- Marketing authorisation holder: TEVA
- Local brand name: CEFACLOR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 June 1996
- Application: NDA050673
- Marketing authorisation holder: LILLY
- Local brand name: CECLOR CD
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 August 1997
- Application: ANDA064156
- Marketing authorisation holder: RANBAXY
- Local brand name: CEFACLOR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 October 1997
- Application: ANDA064165
- Marketing authorisation holder: RANBAXY
- Local brand name: CEFACLOR
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 2 October 1997
- Application: ANDA064166
- Marketing authorisation holder: RANBAXY
- Local brand name: CEFACLOR
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 2 October 1997
- Application: ANDA064164
- Marketing authorisation holder: RANBAXY
- Local brand name: CEFACLOR
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 2 October 1997
- Application: ANDA064155
- Marketing authorisation holder: RANBAXY
- Local brand name: CEFACLOR
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 18 February 1998
- Application: ANDA064206
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: CEFACLOR
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 18 February 1998
- Application: ANDA064204
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: CEFACLOR
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 18 February 1998
- Application: ANDA064205
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: CEFACLOR
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 18 February 1998
- Application: ANDA064207
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: CEFACLOR
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 5 January 2001
- Application: ANDA065057
- Marketing authorisation holder: WORLD GEN
- Local brand name: CEFACLOR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 4 September 2002
- Application: ANDA065058
- Marketing authorisation holder: TEVA
- Local brand name: CEFACLOR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 December 2003
- Application: ANDA065092
- Marketing authorisation holder: RANBAXY LABS LTD
- Local brand name: RANICLOR
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 22 January 2004
- Application: ANDA065146
- Marketing authorisation holder: YUNG SHIN PHARM
- Local brand name: CEFACLOR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 April 2007
- Application: ANDA065350
- Marketing authorisation holder: HIKMA
- Local brand name: CEFACLOR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 February 2012
- Application: ANDA065412
- Marketing authorisation holder: YUNG SHIN PHARM
- Local brand name: CEFACLOR
- Indication: FOR SUSPENSION — ORAL
- Status: approved
Ceclor in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Ceclor approved in United States?
Yes. FDA authorised it on 23 April 1979; FDA authorised it on 28 July 1979; FDA authorised it on 23 May 1996.
Who is the marketing authorisation holder for Ceclor in United States?
FACTA FARMA holds the US marketing authorisation.